Phase I/II Study to Evaluate Nab-paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer (NabucCO)

NCT02109341 Phase 1/Phase 2 COMPLETED

At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) \[Nab-FOLFIRI and Nab-FOLFOX\]. Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both schedules will be evaluated in successive phase II part.

Details

Lead sponsor	Gruppo Oncologico Italiano di Ricerca Clinica
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	148
Start date	2014-02
Completion	2016-01

Conditions

• Metastatic Pancreatic Cancer

Interventions

• Paclitaxel bound albumine

Primary outcomes

• Dose finding safety and activity — 18 months
  To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of the combination Nab-paclitaxel+ Irinotecan+ Leucovorin+ 5-Fluorouracil (Nab-FOLFIRI) and of the combination Nab-paclitaxel+ Oxaliplatin+ Leucovorin+ 5-Fluorouracil (Nab- FOLFOX) in pts with mPC in first-line chemotherapy (CT). To assess efficacy of Nab-FOLFIRI and Nab-FOLFOX in pts with mPC in first-line CT , in term of ORR \[Complete response (CR) + partial responses (PR)\].

Countries

Italy